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Packagehl7.fhir.uv.rwi-pharma
Resource TypeTask
IdTask-scenario4-10-variation-approved.json
FHIR VersionR5

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Narrative

Note: links and images are rebased to the (stated) source

Type II variation approved

TaskType II Variation (variation-type-ii)
Procedure numberVAR-II-2027-0012
Version4
Statuscompleted
Business statusApproved (approved)
RequesterSynthPharma AG
OwnerHealth Authority – Regulatory Review Division
Group identifierurn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be
Authored2027-01-11T10:00:00+01:00
Last modified2027-03-17T09:00:00+01:00

Inputs (from the requester)

Outputs (from the owner)


Source1

{
  "resourceType": "Task",
  "id": "scenario4-10-variation-approved",
  "meta": {
    "versionId": "4",
    "lastUpdated": "2027-03-17T09:00:00+01:00",
    "profile": [
      "http://hl7.org/fhir/uv/apix/StructureDefinition/apix-task"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "identifier": [
    {
      "use": "official",
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-demo",
            "code": "apixtaskinstance",
            "display": "APIX Task Instance ID"
          }
        ]
      },
      "system": "http://example.org/health-authority/task-id",
      "value": "urn:uuid:86c83ea7-80e5-5efa-aa1a-4cd36f9a425e"
    },
    {
      "use": "official",
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-demo",
            "code": "apixregulatorprocedureno",
            "display": "APIX Regulator Procedure Number"
          }
        ]
      },
      "system": "http://example.org/health-authority/procedure-number",
      "value": "VAR-II-2027-0012"
    }
  ],
  "groupIdentifier": {
    "use": "official",
    "system": "http://example.org/health-authority/work-flow-group-id",
    "value": "urn:uuid:60ac55b8-8d46-58ff-b1b2-e8015d4960be"
  },
  "status": "completed",
  "businessStatus": {
    "coding": [
      {
        "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-business-status",
        "code": "approved",
        "display": "Approved"
      }
    ]
  },
  "intent": "proposal",
  "priority": "routine",
  "code": {
    "coding": [
      {
        "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-code",
        "code": "variation-type-ii",
        "display": "Type II Variation"
      }
    ]
  },
  "executionPeriod": {
    "start": "2027-01-15T14:00:00+01:00",
    "end": "2027-03-17T09:00:00+01:00"
  },
  "authoredOn": "2027-01-11T10:00:00+01:00",
  "lastModified": "2027-03-17T09:00:00+01:00",
  "requester": {
    "reference": "Organization/org-synthpharma-ag",
    "display": "SynthPharma AG"
  },
  "owner": {
    "reference": "Organization/org-ema-srm-hmed",
    "display": "Health Authority – Regulatory Review Division"
  },
  "input": [
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "cover-letter",
            "display": "Cover Letter"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-var-cover-letter",
        "display": "Variation cover letter"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "application-form",
            "display": "Application Form"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-var-application-form",
        "display": "Variation application form"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "change-description",
            "display": "Change Description and Justification"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-var-change-description",
        "display": "Change description and justification"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "proposed-labelling",
            "display": "Proposed Labelling"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-epi-annotated-v1",
        "display": "Annotated ePI v1 (proposal)"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "epi-bundle",
            "display": "ePI Bundle"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-epi-clean-v1",
        "display": "Clean ePI v1 (proposal)"
      }
    }
  ],
  "output": [
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "validation-report",
            "display": "Validation Report"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-var-validation-report",
        "display": "Variation validation report"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "approval-letter",
            "display": "Approval Letter"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-var-approval-letter",
        "display": "Variation approval letter"
      }
    },
    {
      "type": {
        "coding": [
          {
            "system": "http://hl7.org/fhir/uv/rwi-pharma/CodeSystem/apix-task-input-output-type",
            "code": "approved-labelling",
            "display": "Approved Labelling"
          }
        ]
      },
      "valueReference": {
        "reference": "DocumentReference/docref-epi-approved",
        "display": "Approved ePI"
      }
    }
  ]
}